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HHT — Spatula, Cervical, Cytological Class II

FDA Device Classification

Classification Details

Product Code
HHT
Device Class
Class II
Regulation Number
884.4530
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K182049excell companyexCellerator Cervical Collection DeviceApril 25, 2019
K153128kolplast ciKolplast Cervical Sample Collection KitJanuary 13, 2017
K141057ningbo hls medical products coDISPOSABLE CERVICAL BRUSHMay 14, 2015
K111681puritan medical products companyHISTOBRUSHJanuary 19, 2012
K083012otto bock pur life sciencePAPCONEApril 9, 2009
K081522bio nuclear diagnosticsBIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGYDecember 5, 2008
K072381cytocoreSOFTPAP CERVICAL CELL COLLECTORJanuary 30, 2008
K062433diamicsDIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEMMarch 16, 2007
K043369rovers medical devicesCERVEX-BRUSH COMBIFebruary 2, 2005
K042527medical action industriesSPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107November 8, 2004
K041018doctor research groupDRG SOFTRELEASEOctober 18, 2004
K013258molecular diagnosticsINPATH E2 COLLECTORMay 31, 2002
K002520rovers medical devicesROVERS SPATULANovember 13, 2000
K001119rovers medical devicesROVERS ENDOCERVEX-BRUSHMay 19, 2000
K991593orifice medicalORIBRUSH - STANDARD - B002June 29, 1999
K991595orifice medicalORIBRUSH - WITH PROTECTIVE TIP - B001June 29, 1999
K983202harwill medical (pty)HARWILL MEDICAL CERVITULA CERVICAL SPATULAMarch 15, 1999
K983599andwin scientificSAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KITDecember 11, 1998
K983428andwin scientificSAFETEX CERVICAL SCRAPER (PLASTIC)November 16, 1998
K980356canadian medical brushCERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010April 16, 1998